Quality Management System Lead

Caldera Medical•Westlake Village, CA

2d•$130,000 - $150,000•Onsite

About The Position

Caldera Medical’s Mission - To Improve the Quality of Life for Women! Message from the Hiring Manager: Caldera Medical requires a senior quality leader to serve as both the on-site Quality Lead for the Westlake manufacturing facility and the enterprise-wide architect and steward of the Quality Management System. As the company grows across multiple sites — including operations in Neuchâtel — maintaining a robust, harmonized QMS that meets ISO 13485, FDA QSR/QMSR, and EU MDR requirements is essential to regulatory standing, product quality, and market access. This role is critical to sustaining audit readiness, driving a culture of continuous improvement, and protecting the company's ability to scale into new markets and sites. Reporting to the Head of Quality, this individual will lead the site QA/QC team, own the corporate QMS, and serve as the primary interface with regulators and notified bodies.

Requirements

Bachelor's degree in Engineering, Life Sciences, Quality Management, or related field.
Minimum 10–15 years of progressive Quality experience in a regulated industry (medical devices preferred; pharma or biotech considered).
Minimum 5 years of direct QMS ownership or leadership (QMS Manager, Quality Systems Lead, or Quality Manager with primary QMS responsibility).
Proven experience designing and maintaining ISO 13485 and ISO 9001 quality management systems in multi-site organizations.
Demonstrated success leading internal and external audits (ISO 13485, MDSAP, FDA QSR, notified body) and managing audit responses.

Nice To Haves

Experience with eQMS or document management systems preferred.
Desired certifications: CQA or CQE (ASQ); Lead Auditor ISO 13485/9001; Six Sigma Black Belt or Lean a plus.
French language skills.
15% travel required.

Responsibilities

Serve as overall Quality lead for the Westlake site; own day-to-day quality operations and long-term quality strategy.
Lead, coach, and develop the site quality team (QA Operations, Quality Engineers, QC/Lab, Document Control, Complaints).
Oversee manufacturing quality controls: incoming inspection, final product release, nonconformance management, and change control.
Establish and monitor site KPIs (defects, scrap, deviations, complaints, CAPA timeliness); drive continuous improvement.
Authority to initiate temporary production holds or shipment holds and escalate to Head of Quality.
Act as global process owner for the QMS across all Caldera Medical sites.
Own and continuously improve the Quality Manual, corporate quality policy, and all core quality procedures.
Ensure all procedures meet ISO 13485, FDA 21 CFR 820/QMSR, and EU MDR requirements.
Lead the internal audit program across all sites; manage notified body, MDSAP, and FDA inspection readiness.
Chair or co-chair the CAPA review board and corporate management review meetings.
Champion a risk-based, data-driven approach to QMS changes and preventive actions organization-wide.